Laura Bush
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In a recent study conducted by the United States Pharmacopeia and the World Health Organization, one third of antimalarial
medicines sampled in three African countries failed tests for potency, purity, and dissolution. A few days after that report
came out, authorities in Syria arrested 65 people for trafficking in counterfeit versions of cancer drugs in Iraq, Turkey,
Lebanon, Iran, and Egypt. Such findings are a harsh reminder of the real risks to drug quality that are present every day
in the global pharmaceutical market.
Recent terrorism events serve as another important reminder. The case of Umar Farouk Abdulmutallab, the "Christmas day" terrorist
who got a US visa despite having been denied one by Britain and after his own father warned American authorities, makes it
clear that sharing information is a critical part of security—whether we are protecting travelers from bombs or patients from
adulterated medicines.
Rx-360, a nonprofit industry consortium formed to improve supply chain security, recommends several steps to combat the threats
posed by falsifiers. Guy Villax, CEO of Hovione and an Rx-360 board member, explained these proposals in a presentation at
the 2009 AAPS conference. In almost all of these measures, pooling data is a central theme.
First, laws should be passed making drug counterfeiting a serious crime with sanctions akin to those for trafficking narcotics,
including jail time. Further, individuals and companies involved in counterfeiting should be "de-barred" from future industry
activity—in all countries. That requires sharing lists and agreeing to enforce judgments made in other jurisdictions.
Furthermore, inspections of API manufacturing operations should be tripled. For that to be possible with today's limited regulatory
resources, Villax says, authorities in countries with robust regulatory systems must trust each others' inspections instead
of duplicating them, because that will free up resources to inspect more facilities. Then, if one agency discovers a falsification,
that information must be passed on to others, and the licenses for that site should be suspended in all countries, not just
in the one whose authorities discovered the problem.
And just as regulators should collaborate on inspections, companies should share supplier auditing data. Rx-360 has a plan
to coordinate supplier audits, to reduce the number of site visits, and thus free up time to make audits more thorough.
Furthermore, Rx-360 has suggested that the industry be on the lookout for situations that offer increased opportunities for
counterfeiting. The 2008 heparin crisis was preceded by illness among the pigs in China from which the heparin active ingredient
is extracted, leading to shortages and price peaks—a strong inducement for foul play. From now on, purchasers should see unusual
events like sudden price peaks as an early warning, and use Rx-360 as a clearinghouse to alert other companies.
To date, more than 40 organizations have signed on to Rx-360. Of course, many companies not involved in this new consortium
may be implementing strong measures within their own firms and networks to ensure supply chain security. Those efforts will
be much more effective, however, if the industry and regulators approach the problem as an industry-wide threat and act together.
Laura Bush is the editor in chief of BioPharm International, lbush@advanstar.com
